Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 5:41 PM
Study NCT ID:
NCT00768794
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2008-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acidophilus for the Treatment and Prevention of Oral Candidiasis in Patients Undergoing Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002180', 'term': 'Candidiasis, Oral'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100843', 'term': 'Lacteol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-30', 'studyFirstSubmitDate': '2008-10-07', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily during radiation treatments to the head and neck region after the development of oral thrush is an effective treatment for oral candidiasis.', 'timeFrame': 'during duration of treatment of 4 weeks.'}], 'secondaryOutcomes': [{'measure': 'To the response of oral candidiasis treated with Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements and to determine efficacy.', 'timeFrame': 'during duration of treatment of 4 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thrush'], 'conditions': ['Oral Candidiasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of using acidophilus to treat oral candidiasis (thrush) caused by radiation therapy to the head and neck region.\n\nThis study will conducted in two parts. In the first part of the study, two participants will begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy, white/yellow coating and/or patches on the tongue and inside of your mouth that are painful, you will begin taking acidophilus capsules twice each day until the last day of radiation therapy.\n\nThe second part of the study is to determine if acidophilus is effective in preventing oral candidiasis (thrush) during radiation therapy to the head and neck region. In the second part of the study three participants will take acidophilus capsules twice each day beginning on the first day of radiation therapy and continuing until the last day of radiation therapy.', 'detailedDescription': 'To determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily during radiation treatments to the head and neck region after the development of oral thrush is an effective treatment for oral candidiasis.\n\nTo determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily beginning on the first day of radiation treatments to the head and neck region prevents the development of oral thrush.\n\nTo assess subjective and objective response of oral candidiasis treated with Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements.\n\nTo assess the efficacy of Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements in preventing oral candidiasis in patients receiving radiation therapy to the head and neck region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck region receiving \\> 50 Gy to head and neck tumor with or without concomitant chemotherapy and/or cetuximab.\n* Age ≥ 18\n* Karnofsky Performance Score of \\> 70\n* History and physical examination within 8 weeks prior to registration\n* Patient must sign study specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.\n* Patients with carcinoma in-situ of the breast, oral cavity, or cervix are eligible.\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.\n* Acute bacterial or fungal infection requiring intravenous or oral antibiotics at study entry\n* Sjoren's syndrome\n* Hypoadrenalism\n* Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol.\n* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.\n* Prior allergic reaction to Lactobacillus acidophilus."}, 'identificationModule': {'nctId': 'NCT00768794', 'briefTitle': 'Acidophilus for the Treatment and Prevention of Oral Candidiasis in Patients Undergoing Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Summa Health System'}, 'officialTitle': 'A Trial Using Acidophilus for the Treatment and Prevention of Oral Candidiasis in Head and Neck Cancer Patients Undergoing Radiation Therapy', 'orgStudyIdInfo': {'id': 'Acidophilus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acidolphilus', 'description': 'In the first part of the study, two participants will begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy, white/yellow coating and/or patches on the tongue and inside of their mouth that are painful, subjects will begin taking acidophilus capsules twice each day until the last day of radiation therapy.', 'interventionNames': ['Dietary Supplement: Acidophilus', 'Dietary Supplement: Acidolphilus']}], 'interventions': [{'name': 'Acidophilus', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Use of Acidophilus in the first part of the study, two participants will begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy, white/yellow coating and/or patches on the tongue and inside of their mouth that are painful, subjects will begin taking acidophilus capsules twice each day until the last day of radiation therapy.\n\nThe second part of the study is to determine if acidophilus is effective in preventing oral candidiasis (thrush) during radiation therapy to the head and neck region.', 'armGroupLabels': ['Acidolphilus']}, {'name': 'Acidolphilus', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The second part of the study is to determine if acidophilus is effective in preventing oral candidiasis (thrush) during radiation therapy to the head and neck region.', 'armGroupLabels': ['Acidolphilus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44304', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summa Health System', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}], 'overallOfficials': [{'name': 'Heather Tharpe, Rn, BSN, OCN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Summa Health System'}, {'name': 'Joyce Neading, RHIT, CTR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Summa Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Summa Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}